BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇵🇱 Poland

    Droplet Pen Needles

    K Number: K143437 · Decision Jun 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    440
    Registration Numbers
    440
    Same Product Code
    687
    Applicant Total
    7
    Review Days
    206

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    Basic Information

    Device Name
    Droplet Pen Needles
    K Number
    K143437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Htl-Strefa S.A
    Date Received
    December 1, 2014
    Decision Date
    June 25, 2015
    Product Code
    FMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMI Needle, Hypodermic, Single Lumen

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    Other Clearances by Htl-Strefa S.A

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    K192082 Droplet Pen Needle 34G
    K171982 DROPLET PEN NEEDLE
    K170988 DropSafe Safety Pen Needle